Spinal Cord Stimulator Lawsuit [November 2024 Update]

Spinal Cord Stimulator Lawsuit Overview

Spinal cord stimulators (SCS) are medical devices implanted to manage chronic pain by delivering electrical pulses to the spinal cord, aiming to disrupt pain signals before they reach the brain.

Though these stimulators and related surgical procedures offer hope for pain relief, numerous patients have reported adverse events and health problems, including electric shocks, nerve damage, device migration, burns, and, in the most tragic cases, death.

According to the FDA, over 80,000 adverse event reports related to SCS devices have been filed since 2008, including nearly 500 deaths.

Spinal Cord Stimulator Lawsuits claim that manufacturers failed to conduct adequate safety testing and to provide necessary warnings, leaving patients vulnerable to severe and often life-altering injuries.

Lawsuits seek compensation for medical costs, emotional distress, and other damages, aiming to hold manufacturers accountable for the harm caused by these devices.

Law firms specializing in medical device lawsuits and medical malpractice cases are investigating claims from individuals who have been impacted by these devices.

If you’ve suffered injuries due to a spinal cord stimulator device, or your loved one has tragically passed away as a result of a spinal cord stimulator operation, you may be eligible to file a Spinal Cord Stimulator Lawsuit and seek compensation.

Contact TorHoerman Law for a free consultation.

Use the chat feature on this page for an instant case evaluation and to get in touch with our lawyers.

Spinal Cord Stimulator Injury Risks

Although these devices offer pain relief for some, their use also involves significant risks that can severely impact a patient’s health and quality of life.

Common issues include infection at the surgical site, device malfunctions, and even neurological complications if the device moves or fails.

Spinal cord injury is also a major risk.

These risks have led many patients to experience further injury instead of relief, with complications that sometimes require additional surgeries.

For some, the implantation process itself can result in adverse effects like dural punctures or allergic reactions to device materials.

Patients considering spinal cord stimulation should weigh these potential complications with their medical providers to make fully informed choices.

Severe complications and injuries linked to spinal cord stimulators include:

• Infection: The implantation procedure carries a risk of infection at the surgical site, which can lead to serious complications if not promptly addressed.
• Device Migration and Malfunction: Issues such as lead migration (movement of the electrodes), hardware failure, or battery problems can occur, potentially diminishing the device’s effectiveness or causing discomfort.
• Neurological Complications: Improper placement or movement of the device can result in nerve damage, leading to symptoms like weakness, numbness, or even paralysis.
• Dural Puncture: Accidental puncture of the epidural space during implantation can cause cerebrospinal fluid leaks, leading to headaches and other complications such as epidural hematoma.
• Allergic Reactions: Some patients may experience allergic reactions to the materials used in the device, resulting in skin irritation or other systemic responses.
• Chronic Pain Worsening: In some cases, the stimulator may not only fail to alleviate pain but can also exacerbate the patient’s original pain condition, leading to increased discomfort and additional pain management needs.
• Scar Tissue Formation: As with many implanted devices, scar tissue can build up around the stimulator, which may impair its function and lead to further complications.
• Electrical Shocks or Burns: Patients have reported sensations of electric shocks or burns caused by device malfunctions, which can be distressing and even injurious if severe.
• Battery Replacement and Surgical Risks: Device batteries may need to be replaced over time, necessitating additional surgeries and bringing cumulative risks related to multiple procedures.
• Psychological Impacts: Patients may experience psychological impacts, including anxiety and depression, particularly if the device causes additional complications or fails to relieve pain as expected.

It’s essential for patients to discuss these potential risks with their healthcare providers to make informed decisions about undergoing spinal cord stimulator implantation.

What is Spinal Cord Stimulation?

Spinal cord stimulation (SCS) is a medical procedure used to manage chronic pain by implanting a device that sends mild electrical pulses to the spinal cord.

These electrical signals interrupt pain messages before they reach the brain, providing relief for patients who suffer from conditions like failed back surgery syndrome, complex regional pain syndrome, or neuropathy.

Often considered a last-resort treatment for those unresponsive to other pain management therapies, spinal cord stimulators aim to improve quality of life, though results can vary significantly.

Understanding the purpose, procedure, types of devices, and potential risks of spinal cord stimulation can help individuals make informed decisions about this treatment option.

Purpose of Spinal Cord Stimulators Explained

Spinal cord stimulators are primarily used to alleviate chronic pain when other treatments, such as spinal surgery, have not provided sufficient relief.

These devices target persistent pain conditions that often stem from spinal cord compression, spinal cord injuries, or issues within the spinal canal, where nerves are highly sensitive.

By delivering mild electrical impulses to the epidural space around the spinal cord, spinal cord stimulators work to intercept pain signals before they reach the brain.

This technology offers relief to patients suffering from severe back pain, leg pain, and neck pain, enabling improved mobility and a potentially reduced need for pain medication.

Unlike traditional pain management options, spinal cord stimulators aim to provide ongoing relief without extensive medication reliance.

This targeted approach is said to help those with debilitating pain regain some degree of normalcy in their daily lives.

How are Spinal Cord Stimulators Implanted?

The implantation of a spinal cord stimulator (SCS) involves a two-step process: a trial phase and, if successful, a permanent implantation.

This staged approach helps determine if spinal cord stimulation provides adequate pain relief before committing to a permanent device.

Step 1: Spinal Cord Stimulator Trial

The spinal cord stimulator trial period begins with a minimally invasive procedure, where thin electrical leads (electrodes) are inserted into the epidural space around the spinal cord.

These leads are connected to an external pulse generator worn outside the body.

Patients usually undergo local anesthesia or mild sedation for this procedure, which allows the orthopedic surgeon to position the leads precisely and test their effectiveness in real-time.

The goal is to see if the device reduces pain enough to justify a permanent implant.

The trial period typically lasts around 5-7 days, during which the patient assesses the level of pain relief and reports any issues.

If the trial is successful, the patient may proceed to the permanent implantation phase.

Step 2: Permanent Implantation

If the patient experiences significant pain relief during the trial, a permanent spinal cord stimulator is implanted.

This process is conducted under local or general anesthesia, and the leads are implanted in the same epidural space as during the trial phase.

However, the pulse generator is now placed within the body, usually under the skin in the abdomen or buttocks.

The leads are connected to this internal pulse generator, which is programmed to provide consistent stimulation to alleviate pain.

Some devices include rechargeable batteries, requiring the patient to regularly recharge the device through an external system, while others use a non-rechargeable battery, which may need replacement surgery after several years.

Post-Procedure and Device Calibration

After implantation, the device is calibrated and programmed to meet the patient’s specific pain relief needs.

Patients are trained to use a handheld remote control, allowing them to adjust the stimulation level or turn the device on and off.

Initial follow-up appointments are crucial for fine-tuning the stimulator settings and ensuring the device functions optimally.

Over time, as the patient’s condition or pain levels change, additional adjustments may be made to maintain effective pain relief.

Recovery and Long-Term Maintenance

Recovery from the implantation procedure can take a few weeks, during which patients are advised to limit certain physical activities to allow the device and leads to settle.

Long-term, patients may require periodic adjustments, and in some cases, the device may need to be repositioned or replaced due to complications like lead migration, device malfunction, or battery depletion.

Proper maintenance and regular medical follow-up ensure that the spinal cord stimulator continues to provide effective pain relief over time.

Types of Spinal Cord Stimulator Devices and Manufacturers

Spinal cord stimulation as a treatment for chronic pain originated in the late 1960s when the first devices were introduced to target pain pathways directly within the nervous system.

Over the following decades, advancements in technology allowed these devices to evolve, providing greater control over pain management with more compact, reliable models.

By the 1990s, spinal cord stimulators had gained FDA approval for broader use, though their effectiveness varied significantly among patients.

Improvements in the 2000s brought rechargeable batteries, high-frequency stimulation options, and patient-controlled settings, further enhancing their appeal as an alternative to long-term pain medication.

Today, spinal cord stimulators are manufactured by multiple medical companies, each producing various models to cater to specific types of chronic pain and patient needs.

Types of Spinal Cord Stimulator Devices and Manufacturers include:

• Traditional Low-Frequency Stimulators: Manufactured by Medtronic, Abbott, Boston Scientific, and others.
• High-Frequency Stimulators: Manufactured by Nevro (HF10), Boston Scientific, and others.
• Burst Stimulation Devices: Manufactured by Abbott (BurstDR) and others.
• Rechargeable vs. Non-Rechargeable Models: Manufactured by Medtronic, Boston Scientific, Nevron, Abbott, and others.
• Fully-Implantable vs. External Power Source Options: Manufactured by Boston Scientific, Abbott, and others.

These types of spinal cord stimulators provide varied methods and technologies to address specific pain needs.

Medical malpractice claims, medical negligence claims, and product liability lawsuits have named several different types of spinal cord stimulators.

Limitations and Risks of Spinal Cord Stimulators

Spinal cord stimulators offer relief for many patients, but they come with notable limitations and risks.

For one, these devices are not universally effective; up to 30% of patients report little to no improvement in their pain levels and opt for removal, even after proper implantation and use.

Complications such as device migration, where the electrode moves from its intended position, can impact the device’s effectiveness and may require corrective spinal surgery.

There’s also a risk of infection at the implant site, which can be severe enough to warrant removal of the device.

In rare cases, patients may experience neurological side effects like numbness or even paralysis due to issues like epidural hematoma or nerve damage during insertion.

Battery life is another limitation, as the devices require battery replacement, which involves additional surgeries over time.

Spinal cord stimulators come at a significant financial cost, and insurance coverage may vary, placing a burden on some patients seeking this therapy.

Do You Qualify for a Spinal Cord Stimulator Lawsuit?

Injuries from spinal cord stimulators can have a profound impact on a person’s life, often turning a hopeful treatment into a daily struggle with new and worsening pain.

For many, these complications limit their mobility, add emotional strain, and affect their ability to work or care for loved ones.

The physical and emotional toll can be overwhelming, leaving individuals to navigate medical issues and the uncertainty of their well-being in the face of ongoing pain.

If you or a loved one has suffered injuries or complications from a spinal cord stimulator, you may be entitled to seek compensation for medical expenses, pain, and the impact on your quality of life.

Contact our law firm today for a free consultation.

Use the chat feature on this page for a free and instant case evaluation.

Attorneys handling injury claims related to spinal cord stimulators can help clients through the legal process, gathering evidence to support their case and assessing damages to understand the impact of the device.

Gathering Evidence for Spinal Cord Stimulator Lawsuits

Building a strong case for a Spinal Cord Stimulator Lawsuit requires gathering comprehensive evidence to demonstrate the impact of the device’s failure on the patient’s life.

Medical records documenting the initial pain condition, treatment attempts, and any complications post-implantation provide critical insight into the extent of harm caused.

Expert evaluations and personal documentation of pain levels, physical limitations, and emotional distress can strengthen the case, illustrating the profound effects of the injuries.

Evidence in a Spinal Cord Stimulator Lawsuit may include:

• Medical Records: Include documentation of the original pain diagnosis, details of the spinal cord stimulator procedure, and records of any complications or subsequent treatments.
• Device Information: Collect details on the specific model of the spinal cord stimulator, manufacturer, and any recall notices or reported issues associated with the device.
• Expert Medical Opinions: Obtain statements from healthcare professionals regarding the medical implications of the device’s failure and expected outcomes.
• Pain and Symptom Diary: Keep a daily record of pain levels, limitations in activities, and emotional or psychological impacts experienced.
• Employment Records: Show documentation of work limitations, lost income, or job changes due to physical complications from the device.
• Correspondence with Manufacturers or Healthcare Providers: Save any communication related to the device, including inquiries about risks, complaints, or service requests.

Damages in Spinal Cord Stimulator Injury Claims

In a legal context, “damages” refer to the compensation awarded to a plaintiff for the harm or losses they’ve suffered due to another party’s actions or negligence.

In Spinal Cord Stimulator injury claims, damages aim to address both the financial and non-financial impacts of the injuries, helping victims recover from the consequences of faulty devices.

These claims seek to cover not only direct costs, like medical bills, but also the broader effects on a person’s quality of life, earning capacity, and emotional well-being.

Potential damages in Spinal Cord Stimulator Lawsuits may include:

• Medical Expenses: Reimbursement for past, current, and future medical bills associated with the injuries, including surgeries, medications, physical therapy, and rehabilitation.
• Lost Wages and Earning Capacity: Compensation for income lost due to time off work and any reduction in earning ability caused by the injuries.
• Pain and Suffering: Damages for the physical pain endured from the injury, as well as emotional suffering such as anxiety, depression, or reduced enjoyment of life.
• Loss of Consortium: Compensation for the impact on relationships with family members and loved ones due to the physical and emotional effects of the injury.
• Punitive Damages: In some cases, additional damages may be awarded to punish the manufacturer for particularly egregious negligence or misconduct.
• Cost of Replacement or Removal: Compensation for costs related to replacing or removing the spinal cord stimulator if it was found to be defective or caused further harm.

TorHoerman Law: Investigating Spinal Cord Stimulators and Related Injury Claims

Spinal cord stimulators, intended to provide pain relief, have left some patients facing severe complications that worsen their condition and quality of life.

For some, device-related issues have led to irreversible damage and, tragically, even death.

Our attorneys are actively investigating spinal cord stimulator injury claims to support affected individuals and hold manufacturers accountable for these life-altering impacts.

If you or a loved one has experienced severe complications or injuries, or if you’ve lost someone due to a spinal cord stimulator, you may be eligible to pursue a legal claim to seek justice and compensation.

Contact TorHoerman Law for a free consultation.

Use the chat feature on this page to find out if you qualify for a Spinal Cord Stimulator Lawsuit instantly.